Tissue Predictors of Abiraterone Benefit

November 11, 2023 updated by: Tianjin Medical University Second Hospital

Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC

This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the HOXB3 (an alternative factor of WNT signaling pathway), FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC (unpublished data). Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.

Study Overview

Status

Completed

Conditions

Detailed Description

It is now accepted that castration-resistant prostate cancer (CRPC) is not really androgen-independent and continues to rely on androgen signaling. Abiraterone is an inhibitor of cytochrome P450 17A1 (CYP17A1) that impairs androgen-receptor signaling by depleting adrenal and intratumoral androgens. After studies showed improved survival with abiraterone, it was approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

mCRPC is a syndrome other than a disease. The mechanisms of mCRPC contain aberrant activation of androgen signaling, abnormal transition between epithelial and mesenchymal and induction of neuroendocrine differentiation (NED). In addition, cellular heterogeneity represents an omnipresent feature in human tumors, which contain cells with diverse morphology, cytogenetic markers, growth kinetics, immunological characteristics, metastatic ability, and sensitivity to therapeutics.

This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC. Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300211
        • Tianjin Medical Unversity Second Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants having indication and planning to receiving abiraterone treatment.

Description

Inclusion Criteria:

  1. Participants who have given consent form;
  2. Patients with a confirmed diagnosis of mCRPC according to EAU 2017 guideline;
  3. Serum testosterone must reach castration level: <50 ng per deciliter;
  4. Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.

Exclusion Criteria:

  1. Participants who are allergic to contrast medium;
  2. Patients were excluded if they planned to receive additional concurrent anticancer therapies;
  3. Patients doesn't sign an informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA response rates
Time Frame: 2 YEARS
PSA response rates between FKBP5(protein)-positive and FKBP5(protein)-negative (including YAP1-positive and NTS-positive) patients; PSA response rates between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
2 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA progression-free survival (pPFS)
Time Frame: 3 YEARS
pPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; pPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
3 YEARS
clinical or radiographic progression-free survival (cPFS)
Time Frame: 3 YEARS
cPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; cPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
3 YEARS
overall survival (OS)
Time Frame: 3 YEARS
OS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; OS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
3 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Second Hospital

Collaborators

The Second Hospital of Hebei Medical University
Tianjin Medical University Cancer Institute and Hospital
Beijing Chao Yang Hospital
Affiliated Hospital of Hebei University
Tianjin Medical University General Hospital

Investigators

  • Principal Investigator: Rong Han, Tianjin Medical University Second Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mCRPC-PA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD can be got by contacting researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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